Standard Operating Procedure for Ointment Filling System
1) Purpose
The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Ointment Filling Machine used in the manufacturing of ocular dosage forms.
2) Scope
This SOP applies to the Ointment Filling Machine used in the production of sterile ocular ointments within the pharmaceutical manufacturing facility.
3) Responsibilities
The responsibilities include the operation, cleaning, and maintenance of the Ointment Filling Machine. The machine operator is responsible for following the procedure, and the maintenance team is responsible for regular maintenance and calibration.
4) Procedure
4.1 Preparation
- Ensure the machine and surrounding area are clean and sanitized.
- Verify that the necessary components and consumables (tubes, caps, ointment) are available and within expiry dates.
- Check that the machine is connected to the appropriate power supply.
4.2 Operation
- Turn on the machine and allow it to perform its self-checks.
- Load the tubes into the feeding system.
- Set the desired fill volume on the machine control panel.
- Initiate the filling process by pressing the start button.
- Monitor the filling process to ensure no overfilling or underfilling occurs.
- Once filling is complete, remove the filled tubes from the machine.
4.3 Post-Operation
- Turn off the machine and disconnect it from the power supply.
- Clean all contact parts and the surrounding area as per the cleaning procedure.
- Record the operation details in the equipment logbook.
4.4 Maintenance
- Regularly inspect the machine for wear and tear.
- Lubricate moving parts as per the manufacturer’s recommendations.
- Perform calibration checks as per the schedule.
- Replace any worn-out parts promptly.
5) Abbreviations, if any
None
6) Documents, if any
- Equipment logbook
- Maintenance record
- Calibration record
7) Reference, if any
GMP Guidelines for pharmaceutical production and equipment handling.
8) SOP Version
Version 1.0
